SERTRALINE HYDROCHLORIDE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)

Dostupno od:

Lake Erie Medical DBA Quality Care Products LLC

INN (International ime):

SERTRALINE HYDROCHLORIDE

Sastav:

SERTRALINE 25 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : - Major depressive disorder (MDD) - Obsessive-compulsive disorder (OCD) - Panic disorder (PD) - Posttraumatic stress disorder (PTSD) - Social anxiety disorder (SAD) - Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are contraindicated in patients: - Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)] . - Taking pimozide [See Drug Interactions (7.1)] . - With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1, 6.2)]. Risk Summary Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator

Proizvod sažetak:

Sertraline Hydrochloride Tablets USP, 25 mg are green colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘6’ on the other side. NDC 55700-562-30                           Bottles of 30 Sertraline Hydrochloride Tablets USP, 50 mg are blue colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘7’ on the other side. Sertraline Hydrochloride Tablets USP, 100 mg  are yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘8’ on the other side. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [See USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Sertraline Hydrochloride Tablets USP
(ser' tra leen hye'' droe klor' ide)
What is the most important information I should know about sertraline
hydrochloride tablets?
Sertraline hydrochloride tablets and other antidepressant medicines
may cause serious side effects. Call
your healthcare provider right away if you have any of the following
symptoms, or call 911 if there is an
emergency.
1. Suicidal thoughts or actions:
•
Sertraline hydrochloride tablets and other antidepressant medicines
may increase suicidal thoughts
or actions in some people 24 years of age and younger, especially
within the first few months of
treatment or when the dose is changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice new or sudden
changes in mood, behavior, actions, thoughts, or feelings, especially
if severe.
•
Pay particular attention to such changes when sertraline hydrochloride
tablets is started or
when the dose is changed.
•
Keep all follow-up visits with your healthcare provider and call
between visits if you are
worried about symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in behavior or mood
2. Serotonin Syndrome. This condition can be life-threatening and
symptoms may include:
•
agitation, hallucinations, coma, or other changes in ment

Svojstava lijeka

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SERTRALINE HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SERTRALINE HYDROCHLORIDE TABLETS.
SERTRALINE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS
IN PEDIATRIC AND YOUNG ADULT
PATIENTS (5.1)
CLOSELY MONITOR FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL
THOUGHTS AND BEHAVIORS (5.1)
INDICATIONS AND USAGE
Setraline hydrochloride tablets are a selective serotonin reuptake
inhibitor (SSRI) indicated for the treatment of (1):
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
DOSAGE AND ADMINISTRATION
INDICATION
STARTING DOSAGE
MAXIMUM DOSAGE
MDD (2.1)
50 mg per day
200 mg per day
OCD (2.1)
25 mg per day (ages 6 to 12)
50 mg per day (ages ≥ 13)
200 mg per day
PD, PTSD, SAD (2.1)
25 mg per day
200 mg per day
PMDD (2.2) continuous dosing
50 mg per day
150 mg per day
PMDD (2.2) intermittent dosing
50 mg per day during luteal phase only 100 mg per day during luteal
phase only
If inadequate response to starting dosage, titrate in 25 to 50 mg per
day increments once weekly in MDD, OCD, PD,
PTSD, and SAD (2.1)
See Full Prescribing Information for titration in PMDD (2.2)
Hepatic impairment:
Mild: Recommended starting and maximum dosage is half recommended
dosage (2.3)
Moderate or severe: Not recommended (2.4)
When discontinuing sertraline hydrochloride tablets, reduce dose
gradually (2.5, 5.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg and 100 mg (3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAO